Triamcinolone Acetonide Impurity 53 CAS 61618-63-1

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.61618-63-1
Molecular FormulaC21H25FO4
Molecular Weight360.42 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Triamcinolone Acetonide Impurity 53 CAS 61618-63-1 chemical structure

Description

CATO supplies Triamcinolone Acetonide Impurity 53 (CAS 61618-63-1), a pharmacopoeial impurity reference standard (molecular formula C21H25FO4, MW 360.42 g/mol) used for the identification and quantification of trace impurities in APIs.

Triamcinolone Acetonide Impurity 53 (C21H25FO4) contains a flavonoid core, a hydroxyl group, an ether linkage, fluorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC21H25FO4
Molecular Weight360.42 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1974
Halogen ContentF-containing

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